Re-engineering the clinical approach to suspected cardiac chest pain assessment in the emergency department by expediting research evidence to practice using artificial intelligence

INTERVENTION: This study will use AI‐based support for clinical decision in a system‐wide approach. Real‐time health data will be assimilated within the clinical decision‐support tool which will be deployed in South Australian emergency departments. This AI clinical support aid will provide clinicians with objective patient‐specific diagnostic probabilities and prognostic assessments alongside recommended evidence‐based clinical management. The AI‐based support will be assimilated systems wide thus obtaining an opt‐in participant consent form will be operationally unfeasible. However, all patients will be able to opt‐out of providing their data at any point of the study. To enable informed patient participation, posters and information sheets will be accessible to patients, their clinical team/clinician and/or their next‐of‐kin. In the hospitals allocated to the intervention arm, real‐time health data will be assimilated within the electronic decision‐support tool being developed in partnership with Siemens Healthineers. This will be a web‐based tool, accessible on any computer or mobile device, and will require login credentials. Data assimilation will occur in an automated manner where possible, with manual entry occurring only as required (determined by electronic data system maturity at site). The decision‐support tool will then provide clinicians with objective patient‐specific diagnostic probabilities (i.e. the likelihood for Type 1 MI, vs Type 2 MI, vs cardiac injury etc.) and prognostic assessments alongside recommended clinical management. Specifically, the AI algorithm will report the probabilities for the various types of myocardial infarction and myocardial injury. Importantly, since a therapeutic evidence base exists only for Type 1 myocardial infarctio CONDITION: Acute Coronary Syndromes; ; Acute Coronary Syndromes Cardiovascular ‐ Coronary heart disease Emergency medicine ‐ Other emergency care PRIMARY OUTCOME: The primary outcome will be the composite endpoint (EP):; ‐Cardiovascular mortality; ‐New or recurrent MI defined by the current 4th Universal Definition of Myocardial Infarction; ‐Unplanned hospital re‐admission: non‐elective coronary revascularisation; cerebrovascular accidents; atrial or ventricular arrhythmia; congestive cardiac failure without MI; PE and aortic dissection as documented by a hospital discharge summary. ; N.B All in‐hospital myocardial infarctions (MI) within 12 hours of presentation will be excluded from primary outcomes.; ; All data for in‐hospital care will be obtained by data linkage of public and private hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS).. Where required, paper medical records will be sought.; ; Clinical outcomes will be assessed by an independent clinical events committee and use blinded end‐point adjudication. ; [30 days post‐index presentation] SECONDARY OUTCOME: All‐cause mortality ; ; All data for in‐hospital care will be obtained by data linkage of public and private hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS).. Where required, paper medical records will be sought.[30‐days and 12 months post‐index presentation] Cardiovascular mortality ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; Clinical outcomes will be assessed by an independent clinical events committee and use blinded end‐point adjudication. ; ; ; ; ; ; Clinical outcomes will be assessed by an independent clinical events committee and use blinded end‐point adjudication. [30‐days and 12‐months post‐index presentation] INCLUSION CRITERIA: Patients presenting to the emergency department will be considered eligible for analysis if they meet all of the following: ; All data for in‐hospital care will be obtained by data linkage of public and private hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS).. Where required, paper medical records will be sought. ; Clinical outcomes will be assessed by an independent clinical events committee and use blinded end‐point adjudication. [30‐days and 12 months post‐index presentation] Health‐related quality of life (EQ‐5D‐5L) ; This data will be acquired through surveying of participants at specified timepoints. [30‐days, 6‐and 12‐months post‐index presentation.] Measures of in‐hospital care: coronary angiography at discharge consistent with guidelines ; This outcome will be assessed through linkage of health system data systems. [30‐days and 12 months post‐index presentation] Measures of in‐hospital care: cardiac medications at discharge consistent with guidelines ; This outcome will be assessed through linkage of health system data systems. [30‐days and 12 months post‐index presentation.] Measures of in‐hospital care: echocardiography at discharge consistent with guidelines ; This outcome will be assessed through linkage of health system data systems. [30‐days and 12 months post‐index presentation] Measures of in‐hospital care: stress testing at discharge consistent with guidelines ; This outcome will be assessed through linkage of health system data systems. [30‐days and 12‐months post‐index presentation] New or recurrent MI defined by the current 4th Universal Definition of Myocardial Infarction. ; All data for in‐hospital care will be obtained by data linkage of public and private hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS).. Where required, paper medical records will be sought. ; Clinical outcomes will be assessed by an independent clinical events committee and use blinded end‐point adjudication. [30‐days and 12 months post‐index presentation] Re‐presentation to any emergency department with suspected cardiac chest pain. ; All data for in‐hospital care will be obtained by data linkage of public and private hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS).. Where required, paper medical records will be sought. ; Clinical outcomes will be assessed by an independent clinical events committee and use blinded end‐point adjudication. [30‐days and 12‐months post‐index presentation] Representation with acute and chronic myocardial injury. ; All data for in‐hospital care will be obtained by data linkage of public and private hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS).. Where required, paper medical records will be sought. ; Clinical outcomes will be assessed by an independent clinical events committee and use blinded end‐point adjudication. [30‐days and 12 month post‐index presentation] Representation with myocardial infarction or unstable angina ; All data for in‐hospital care will be obtained by data linkage of public and private hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS).. Where required, paper medical records will be sought. a) Clinical features of chest pain or suspected ACS as the principal cause; and b) At least one high‐sensitivity troponin T assay is drawn; and c) Age of 18 years or older ; [30‐days and 12 months post‐index presentation] Resource utilisation over 12 months: Medicare data among consenting patients using Medical Benefits Schedule (MBS), medication use from Pharmaceutical Benefits Schedule (PBS) and inpatient admissions from the AN‐Diagnosis Related Group (DRG) version 8.0. ; This secondary outcome data will be acquired through the SA Health data infrastructure for all SA residents. This data will be obtained by data linkage of public and private hospital admissions and care through systems and, from Medicare (Medical Benefits Schedule (MBS), Pharmaceutical Benefits Schedule (PBS)), and in‐patient admissions from the AN‐Diagnosis Related Group (DRG).[12 months post‐index presentation] Significant bleeding using Bleeding Academic Research Consortium (BARC) criteria. ; All data for in‐hospital care will be obtained by data linkage of public and private hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS).. Where required, paper medical records will be sought. ; Clinical outcomes will be assessed by an independent clinical events committee and use blinded end‐point adjudication. [30‐days and 12‐months post‐index presentation] Unplanned hospital re‐admission: non‐elective coronary revascularisation; cerebrovascular accidents; atrial or ventricular arrhythmias; congestive cardiac failure without MI; PE and aortic dissection as documented by a hospital discharge summary. ; All data for in‐hospital care will be obtained by data linkage of public and private hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS).. Where required, paper medical records will be sought.